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Prediction of Neonatal Hyperbilirubinemia (2010ICTPAGR)

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01109277
First received: April 21, 2010
Last updated: January 18, 2011
Last verified: April 2010
History of Changes
  Purpose

Objective: To develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.

Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive transcutaneous bilirubin (TcB) values could reliably predict significant neonatal hyperbilirubinemia.

Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from January 2008 to December 2010 will be reviewed.

The registry includes prospectively collected data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after discharge). TcB and TSB values are plotted on a hour-specific chart.

A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics 2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.

Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy threshold level according to the AAP 2004 guidelines

Statistics: Independent and joint effects of various clinical factors on the development of significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to develop the strategy. At each step, CHAID chooses the independent (predictor) variable that has the strongest interaction with the dependent variable. Categories of each predictor are merged if they are not significantly different with respect to the dependent variable.


Condition
Hyperbilirubinemia, Neonatal

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: An Evidence-based Strategy for Assessing the Risk of Significant Neonatal Hyperbilirubinemia

Resource links provided by NLM:

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Risk of significant hyperbilirubinemia assessed by an evidence-based strategy [ Time Frame: Birth to 14th postnatal day ] [ Designated as safety issue: No ]
    Risk for significant hyperbilirubinemia (defined as serum bilirubin values above the phototherapy threshold according to the American Academy of Pediatrics 2004 guidelines) assessed by a strategy which will combine clinical risk factors and non-invasive TcB measurements


Estimated Enrollment: 3500
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy term and late-preterm neonates

  Eligibility

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Healthy term and late-preterm neonates

Criteria

Inclusion Criteria:

  • Healthy term and late-preterm neonates

Exclusion Criteria:

  • Admission to the NICU
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109277

Locations
Greece
Well-baby nursery, Department of Pediatrics, University Hospital of Patras
Patras, Greece, 26504
Sponsors and Collaborators
University of Patras
Investigators
Study Director: Anastasia Varvarigou, Prof Neonatal Intensive Care Unit, Department of Pediatrics, University Hospital of Patras
Principal Investigator: Sotirios Fouzas, MD Neonatal Intensive Care Unit, University Hospital of Patras
Principal Investigator: Aggeliki Karatza, MD Neonatal Intensive Care Unit, University Hospital of Patras
Principal Investigator: Lito Mantagou, MD Pediatric Department, University Hospital of Patras
  More Information

No publications provided

Responsible Party: Fouzas Sotirios, Neonatal Intensive Care Unit, Department of Pediatrics, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT01109277     History of Changes
Other Study ID Numbers: 2010ICTPAGR
Study First Received: April 21, 2010
Last Updated: January 18, 2011
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013